views & REVIEWS The thinking doctor’s guide to placebos PERSONAL VIEW Rudiger Pittrof, Ian Rubinstein
A
recent high profile publication indicating a lack of efficacy of selective serotonin reuptake inhibitors (SSRIs) in mild to moderate depressive illness (PLoS Med 2008;5(2):e45) showed that clinicians routinely make use of the placebo effect—but from a position of ignorance rather than intention. The primary ethical objection to using placebos is that generally it means that deception is involved on the part of the clinician—that is, clinicians know that they are prescribing a placebo, but patients do not know that this is what they are being given. However, we believe that there is a way whereby clinicians can use the placebo knowingly yet still stay within the ethical constraints of modern medical practice. The practice of evidence based medicine is the way to overcome this deception. Published evidence applies to a patient only if that patient has similar characteristics to patients in the study population. Even if this is the case, their response can rarely be accurately predicted. This is one of the problems with evidence based medicine: often its application to the individual is under less than ideal conditions. However, where a study shows a response of the placebo in comparison with the baseline then that is precisely what the study shows. It is possible to state with confidence that, were the conditions of treatment to be replicated as in the study, the patient would have a statistical likelihood of responding to the placebo, just as we can say that it is statistically likely that the patients would respond to the active intervention. There is thus a response whose cause is debatable but genuine. On strictly scientific grounds no deception would be involved in referring to this response as an evidence base. We think that clinicians can use placebos ethically while remaining within the spirit of scientific, evidence based medicine. To be evidence based, they should prescribe placebos similar to those used in randomised controlled trials that show an improvement over baseline. Clinicians could then be 1020
confident in the strength of the evidence and could tell patients that treatment X has been shown in trials to result in an improvement in similar patients. Publishers will have to facilitate the appropriate use of placebo treatment by insisting on a complete description of the placebo in question. The chief ethical objection to the use of placebos is that it involves less disclosure of facts to the patient. But we consider that the ethical use of placebo would involve more disclosure. This would involve discussion of the side effect profile and toxicity versus expected effectiveness of the usual treatment or placebo. For example, when advising a patient about treatment for mild to moderate depression clinicians might explain that use of SSRIs may be associated with a higher risk of suicide attempts (BMJ 2005;330:396) and that about 80% of the benefits of SSRIs might be attributable to a placebo effect (PLoS Medicine 2008;5(2):e45). In men with erectile dysfunction we can adequately predict that, in comparison with baseline, their confidence, self esteem, and erectile function are likely to improve when they take a placebo (J Gen Intern Med 2006;21:1069-74). Although the improvement will be less than if they took the active drug, there would be no risk of drug interactions, cardiovascular illness, or dangerous side effects. For many patients a low risk of side effects is more important than a high probability of relief of symptoms. Indeed, where an effective placebo treatment exists for a condition, not offering it may be unethical, as we cannot second guess the importance that patients attach to different effects (or side effects) of the treatment. Anecdotally, we have seen many risk averse patients who would happily accept reduced benefits for much reduced risks. Given that the use of placebo treatments is not risk free, clinicians need to adhere to a clear strategy for their safe use. Our recommendations are similar to those of Lichtenberg and colleagues (Journal of Medical Ethics 2004;30:551-4). A placebo may be used where:
• The clinical evidence indicates that a placebo may be useful in a given clinical situation • A response to placebo treatment does not preclude the possibility of the patient having a dangerous condition • Placebo treatment, as a formal trial of treatment, is regularly reviewed (ineffective placebo treatment should be discontinued immediately) • There is no agreed “gold standard” treatment • Placebo treatment is initiated after full discussion with the patient of the options • The patient is made aware that other treatments are available that may be more effective, if this is the case • The patient has given informed consent and this has been documented, and • The patient is given full disclosure of the nature of the placebo treatment, including the evidence base, if they ask about it. If these principles are adhered to, placebo treatments would not only be evidence based and cost effective but would offer the best option for respecting patients’ autonomy. Paradoxically, where evidence of a benefit of placebo treatment exists, not discussing it and, where indicated, prescribing it should be seen as unethical. Rudiger Pittrof (
[email protected]) is consultant in integrated sexual health and HIV, Enfield, and Ian Rubenstein is a general practitioner, Enfield A longer version of this article with references is available on bmj.com BMJ | 3 may 2008 | Volume 336
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Dr Allinson, best known for the bread with “nowt taken out” Medical Classics p 1023
review of the week
Mortal thoughts A new meditation on death by Julian Barnes is perfect for doctors in a similarly anxious state about the grim reaper, finds John Quin Thanatophobe—well, who isn’t one? An old boss, then in his 60s when I was in my 20s, once expressed amazement that I should think daily of death. The top man blithely never thought of the Big One. Julian Barnes does—“at least once each waking day.” He’s an expert “pit-gazer” and suffers “intermittent nocturnal attacks” of bolt upright panic. He regards his fear of death, though, as “low-level, reasonable, practical.” He wonders whether worrying about it can be another form of male boasting: “Night sweats, screaming—Ha!—that’s primary school stuff . . . MY FEAR OF DEATH IS BIGGER THAN YOURS AND I CAN GET IT UP MORE OFTEN.” This is the funniest book about death since Evelyn Waugh’s The Loved One. Barnes says that “of all the professions, medicine is the one most likely to attract people with high personal anxieties about dying.” And that “this is good news in one major sense—Doctors are Against Death; less good in that they may unwittingly transfer their own fears onto their patients, over-insist on curability, and shun death as failure.” His own GP is writing about death too, a paper full of literary references. “Hey, that’s my territory,” he realises and then wonders if he is at the start of “a long preliminary conversation” between himself and what may turn out to be his own “death-doctor.” He admires her piece, notes her distaste for the overmedicalisation of death, but has reservations about her view of life as a narrative and death as the end of the story. Barnes thinks life is just “one damn thing after another—a gutter replaced, a washing machine fixed,” that it is of little if any meaning and ends with a punchline to a joke we don’t get. Barnes has a “vicious awareness that this is a rented world.” He thinks “death is the one appalling fact that defines life; unless you are constantly aware of it, you cannot begin to understand what life is about; unless you know and feel that the days of wine and roses are limited, that the wine will madeirize and the roses turn brown . . . there is no context to such pleasures and interests as come your way on the road to the grave.” All very well, but he knows he can’t face death down, not with words. He admits to limited experience of seeing dead people. Death has ceased to be with us in the house. He fears “the catheter and the stairlift, the oozing body and the wasting brain.” The book is deliberately and enjoyably discursive, BMJ | 3 MAY 2008 | Volume 336
with nods to the usual haunted greats like Larkin, Flaubert, and Montaigne—“since we cannot defeat death, the best form of counter-attack is to have it constantly in mind.” And as chummy as an undertaker he quotes Maugham growling that we die as dogs die, extending the simile: “We die as well-groomed, well-tranquilised dogs with good health insurance policies might die. But still caninely.” Thanks a lot, pal. Barnes is thumpingly realistic about his own future: “I expect my departure to have been preceded by severe pain, fear, and exasperation at the imprecise or euphemistic use of language around me”; “Unknown person dies, not many mourn.” That is our likely obituary in the eyes of the world. My brother-in-law once told me about an uncle of his who died but of whom no one could remember anything except that he could eat a digestive biscuit whole. We were silent for a bit then laughed hard. That this is what it should come to, your entire existence reduced to the ability to scoff a biscuit. Barnes would love to think that we are not a number, that we are free men, but he knows that when you get down to it we are all just waiting to be crunched. As if by an expert oenophile all the options concerning thinking about death are examined here, sniffed, tasted, rolled around the palate—and then spat out. Barnes seems to be getting close when he suggests that “God might have set up His own experiment, with us playing rat.” Certainly this is how this book reads, with the writer in a trap, like a doctor who looks at all the differential diagnoses and investigates them, opening and closing all the doors, only to find that death is the ultimate pyrexia of unknown origin, a problem unresolved by observation. Death’s virtues, Barnes suggests, are “at best artisanal: diligence, stubborn application and a sense of contradictoriness which at times rises to a level of irony; but it doesn’t have enough subtlety, or ambiguity, and is more repetitive than a Bruckner symphony.” Maybe, however, he’d be cheered in his graveyard visits by Marcel Duchamp’s epitaph, “D’ailleurs, c’est toujours les autres qui meurent” (“Besides, it’s always other people who die”). Barnes on death, then: as bracingly real as a tsunami of variceal blood over your flashy new scrubs. John Quin is consultant physician, Royal Sussex County Hospital, Brighton
[email protected]
Nothing to be Frightened of Julian Barnes Jonathan Cape, £16.99, pp 250 ISBN 978 0 224 08523 6 Rating:
****
“Of all the professions, medicine is the one most likely to attract people with high personal anxieties about dying” 1021
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What goes up must come down FROM THE FRONTLINE Des Spence
Until recently the statement “You can’t lose on property” was heard at dinner party tables across Britain. Many of us have seen our greatest financial investment, our home, double in value in a decade. Many doctors are sitting on property worth a million pounds or more. Housing wealth has fuelled consumers’ spending and filled tax coffers. This in turn has seen a bonanza in public spending such as on the NHS. But our society is dying from consumption. We have cars and convenience in all its guises and are obsessed with superficial beauty but scarred by a hideous introspective individualism. This is an unhappy society losing sight of its values. Even in the NHS more money has delivered little—squandered on glitzy capital projects; and pay rises seem merely to have fanned discontent. Are we heading for an economic crash? Many people have borrowed big to speculate on property, exposing themselves to huge personal liabilities. So, if mortgage costs increase and property prices fall, those who have speculated on second or buy to let homes may be forced
to sell, worsening the situation further. Hoping for a softer landing, the government has pumped first £50bn into the bank Northern Rock and recently a further £50bn of bank bonds to underwrite mortgage loans. This sum, £100bn, is roughly the annual cost of running the NHS and far exceeds the total additional investment in the NHS in the last decade. A recession would be good for many of us. Life in the recessions of the 1970s and 1980s was at least bearable. Hardship focuses minds, gives us perspective, and spawns activism and collectivism. The NHS would be forced to look to its core work and to value clinical staff. The numerous stupid “seems like a good idea” NHS initiatives would never materialise. Who knows, a recession might even be better for society, forcing us to value what we have, not what we think we want. A painful crash might free those hostages to affluence—the worried well and those suffering from materialistic melancholy—to live properly again. Perhaps losing isn’t so bad after all. Des Spence is a general practitioner, Glasgow
[email protected]
Food, injurious food
COLIN CRISFORD
PAST CARING Wendy Moore
A longer version of this article with sources is available on bmj.com 1022
With rumblings about the colourings, flavourings, and preservatives secreted in our everyday food growing loud enough to make us choke on our television dinners, it is tempting to yearn for a golden age when we could all trust in the purity of good honest victuals. Certainly our Victorian ancestors tucked happily into their daily bread and butter, washed down with quantities of tea and coffee, in the confidence that the basic ingredients they bought from their friendly corner shop were entirely wholesome—at least until they were disillusioned by Arthur Hill Hassall. A London GP with a penchant for making trouble, Hassall (1817-94) first turned his inquisitive mind to examining, with the novel aid of a microscope, the water his fellow citizens nonchalantly downed. As any Londoner with half decent eyesight could plainly view the carcases, rotting vegetables, and sewage floating down the Thames, the minute life forms that Hassall revealed in the engravings of his 1850 book prompted little
surprise—but certainly aided the sanitary reformers. Emboldened by his discoveries Hassall next trained his microscope on his coffee, in which he was indignant to find a bounty of unlikely ingredients, including rye, beans, peas, and burnt sugar. Reporting his findings to the Botanical Society of London he found himself at the centre of media interest, specifically from Thomas Wakley, editor of the Lancet. Never happier than when he was upsetting somebody, Wakley persuaded Hassall to conduct a systematic investigation of all the major foods and drinks on sale in the capital. Grandly titling this inquiry the Analytical Sanitary Commission, though in reality it was mainly just Hassall and his trusty microscope, Wakley published the findings in anonymous weekly and fortnightly reports over the next four years. A respectable GP by day, by night Hassall skulked around the city’s bakeries, grocers, and liquor shops, clandestinely obtaining his supplies, then burnt the gaslight
examining their contents. Much to his disgust he identified mashed potatoes and alum in bread, turnips in marmalade, tapioca in cocoa, and sulphuric acid in gin. Of 36 samples of sugar 35 contained sugar mites; more than half the samples of milk were diluted; and tea was so adulterated that some contained no tea leaves whatsoever. Most shockingly, sweets with such alluring names as “kiss-me-now” contained such high levels of lead based colourings that many were “quite poisonous.” Overall, Hassall later recorded, “adulteration was the rule and purity the exception.” The published results prompted a barrage of libel threats from the shopkeepers fearlessly named, though none of them was pursued, and widespread outrage from the press and public, leading ultimately in 1860 to the first legislation regulating food and drink. The labour and anxiety of his toils made Hassall ill, he subsequently asserted, but without his efforts we might all be ill a lot more often today. Wendy Moore is a freelance writer and author, London
[email protected] BMJ | 3 mAY 2008 | Volume 336
VIEWS & REVIEWS
The value of pulp fiction There is more to great (such as Racine BETWEEN literature than good Mudge, son of a THE LINES writing, of course, for Frenchwoman from even the most arrant Bordeaux and a BritTheodore Dalrymple nonsense can be well ish grocer, who had written. And it is my a tendency to disimpression that the appear into Higher pulp writers of yesSpace, especially teryear were better whenever he heard stylists than the pulp music by Wagner) writers of today. was painted a Algernon Blacksoothing deep wood, for example, green, “calculated to who lived from 1869 induce calmness and to 1951, was a fine repose of mind.” Dr stylist whose prose Silence chose his even contained subcolour wisely: green tle psychological and is indeed the colour social observations. of anxiolysis. Dr Silence chose his His plots are mainly T h e ch a i r s i n colour wisely: green absurd, but his urbanthe waiting room is indeed the colour of ity is pleasurable. For were fixed to the anxiolysis example, The Wings of floor, for Dr Silence Horus, in which a man had observed that of overheated imagiwhen people were nation believes himself possessed by agitated they tended not only to shift the old Egyptian god, takes place before in their chairs but to shift their chairs the first world war in an Egyptian hotel themselves, and this set up a kind of to which rich invalids have been sent vicious circle: the more they moved, by their doctors to recover. Blackwood the more agitated they became. A fixed writes, “Excess and bed were their rouchair maketh a calm patient. tine. They lived, but none of them got It so happens that in several of the better.” That is very good. prisons I have visited, particularly those Similarly, in The Doll, Madame that were privately run, the chairs in Jodzka, the Polish governess, is horrithe interview rooms were fixed to the fied to see her charge’s ugly little doll floor—though more, I suspect, to precome alive. “Making no audible sound, serve property and prevent the physical she screamed in her mind.” That, too, expression of agitation than to prevent is very good. its development in the first place. One of Blackwood’s heroes is John Just in case the wise provisions of Silence, “rich by accident and by choice green walls and immobile chairs failed a doctor.” He specialises in patients with completely to calm the nerves of the metaphysical problems, or tangles with patients, Dr Silence had a button he the supernatural, and naturally enough could press that released a narcotic gas, his practice attracts the occasional luna“swiftly effective but harmless,” into the tic. For this Dr Silence is well prepared, room. I am not sure whether Dr Silence for he has two waiting rooms: “One, had a gas mask to avoid himself the intended for persons who imagined soporific effects of the gas. they needed spiritual assistance, when It will be seen from this brief conreally they were only candidates for spectus of Blackwood’s work that the the asylum, had padded walls, and was reading of well selected pulp fiction is well-supplied with various concealed not a complete waste of time and may contrivances by means of which sudbe indulged in without a sense of guilt. den violence could be met and instantly In fact, it can even be recommended overcome.” for those in need of suggestions for The other waiting room, for people improvements to the service. with genuine metaphysical illnesses Theodore Dalrymple is a writer and retired doctor BMJ | 3 MAY 2008 | Volume 336
Medical classics A System of Hygienic Medicine (1886) and The Advantages of Wholemeal Bread (1889) By Thomas Allinson Thomas Allinson (1858-1918) was a late Victorian doctor whose health maintaining beliefs included the promotion of a diet rich in fruit and vegetables and the avoidance of smoking and alcohol. While predominantly accepted in the present day, his views were often controversial to the fin de siècle British medical establishment and he was ultimately removed from the medical register. Allinson qualified in Edinburgh in 1879. He gained diverse medical experience as a police surgeon, ship’s doctor, and Poor Law practitioner, but the mainstay of his practice was conducted at a surgery in London. A voluminous scholar, Allinson wrote 13 books and more than a thousand articles on health related issues. Best known was A System of Hygienic Medicine, in which he emphasised his central belief in the maintenance of good health over the treatment of disease. Allinson, a passionate vegetarian, advocated a strict regimen of nutritious food, fresh air, and exercise while avoiding tea, coffee, tobacco, salt, and meat. Drugs, including the popular opiates, were vociferously criticised. Arguably his most strongly held belief formed the title of The Advantages of Wholemeal Bread. Allinson viewed stone ground wholemeal flour as of the utmost nutritional value and encouraged the general public to make wholemeal bread a regular dietary constituent. He opposed the use of bread whitening agents. Critics may highlight the conflicting interest of Allinson’s Natural Food Company, set up to promote and supply wholemeal bread and flour. Yet the passion with which Allinson championed wholemeal foods would seem to have transcended profit concerns. Furthermore, Allinson’s convictions preceded the company’s foundation by several years. Orthodox medical Allinson: at odds with opinion was at variance orthodox medical views with a number of Allinson’s views, particularly on smoking, which was moderately encouraged, and the use of medicines. Dr Allinson’s disputes with the medical profession culminated, in 1892, with his being charged with “infamous conduct” and struck off the medical register. The General Medical Council adjudged that he had contravened professional standards through his criticism of colleagues’ therapeutic practices and his use of advertisement for monetary gain. Three years later he was prosecuted and fined for the unsanctioned use of his LRCP title. It may be argued that Dr Allinson was a man ahead of his time. Certainly his dietary advice and abstemious approach to alcohol and smoking resonate strongly in the present day. However, not all of his views—notably his opposition to childhood vaccination—remain credible. Today Allinson is best known for the bread with “nowt taken out,” which continues to bear his name. John A S Beard, GP trainee and MSc student in history of science, technology, and medicine, Oxford johnbeard@ doctors.org.uk
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